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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name X-Ray, Tomography, Computed, Dental
510(k) Number K261748
Device Name Dental Cone-beam Computed Tomography (mDX-15P Series)
Applicant
Hefei Meyer Optoelectronic Technology, Inc.
#668 Wangjiang W. Rd.
High & New Tech. Industry Development Zone
Hefei,  CN 230088
Applicant Contact Zixuan Zhao
Correspondent
Landlink Healthcare Technology (Shanghai) Co., Ltd.
Rm. 1308, Baohua International Plz.,
West Guangzhong Rd. 555, Jingan District
Shanghai,  CN
Correspondent Contact Kyra Kang
Regulation Number892.1750
Classification Product Code
OAS  
Date Received05/28/2026
Decision Date 07/23/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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